The Accreditation Review Board
meets 3 times a year to review laboratory applications and determine
accreditation status. The board meets during the annual meeting
to address administrative issues and polices with regards to changes
in standards and other pertinent regulatory issues.As policies are
adopted or changed, the junior Co-chair maintains the records.
These polices have been approved by the ASHI Board of Directors.
Updates will be posted quarterly. New policies since the last update
will be designated as [New].
| POLICY NO. |
POLICY NAME: |
| Review Policies |
R-01-99, M-1-04 |
Definition of Possible Evaluation Outcomes |
R-02-99 |
Information to Provide to Inspector |
R-03-99 |
Guidelines for Presentation of Evaluation Summary to ARB |
R-04-99 |
Egregious Actions Requiring Immediate Action |
R-05-99- retired |
|
R-06-99 |
Inspection Requirement Following Lab Relocation |
R-07-99 |
Review of the Labs of the Accreditation Program Director & Chairs |
R-08-99, M-1-02, M-2-04 |
Continuing Education Requirements |
R-09-99, M-1-02, M-2-02 |
Test Validation Submission Requirements |
R-10-99, M-1-06 |
Benchmarks for Review of High Volume Laboratories |
R-11-99, M-1-02 |
Review of Director Portfolios/Qualifications |
R-12-99 |
Accreditation Certificate Cover Letter |
R-13-99, M-1-04 |
ABO and/or Rh Typing |
R-14-99, M-1-02 |
Proficiency Testing Corrective Action |
R-15-99, M-1-02, M-2-03, M-2-07 |
Inspections by Members of the ARB |
R-16-00, M-1-02 |
Inspection Requirements Following Change in Lab Director or
Technical Supervisor |
R-17-00 |
CLIA Certification Requirement for Labs doing HLA Typing
for the NMDP Donor Registry |
R-18-00 |
Internal Proficiency Quality Control (Monthly Unknown) Guidelines |
R-19-00, M-1-03, M-2-06, M-3-07 |
Level of Proficiency Testing and Clinical Technology |
R-20-00- retired |
|
R-21-00, M-1-03 |
Accreditation Requires Clinical Activity |
R-22-01, M-1-04, M-2-05, M-3-06 |
Determination of DNA Typing Resolution |
R-23-01, M-1-03 |
Lot Validation for Commercial Molecular Typing Kits |
R-24-01, M-1-03, M-2-05, M-3-06 |
HLA High Resolution Molecular Typing class I and class II Proficiency Testing Requirements |
R-25-02, M-1-03 |
Director/Technical Supervisor Approval for New Areas of Accreditation and/or Technologies |
R-26-02, M-1-04 |
Transfusion Support Accreditation |
R-27-02 |
Bottled Water Quality |
R-28- retired |
|
R-29-03 |
Deficiencies Overruled by ARB |
R-30-04, M-01-06 |
Plan of Action from New Directors of Multiple Labs or Part-time Directors |
R-31-04, M-01-06 |
Out of Cycle Processing of Laboratory Reviews |
R-32-04 |
Solid Organ Transplantation: Deceased Donor Accreditation |
R-33-04 |
Solid Organ Transplantation: Live Donor Accreditation |
R-34-04 |
Proficiency Testing Requirements for Antibody Testing by Multiple Methods |
R-35-06 |
Alternatives to Formal External Proficiency Testing |
R-36-06 |
Proficiency Testing Accepted by ASHI |
R-37-07 |
Null Allele Discrimination |
R-xx-xx |
|
| |
| Operational Policies |
O-01-99, M-1-03 |
Employment Conflict of Interest for ARB Members |
O-02-99 |
ASHI Membership Requirement for ARB |
O-03-99 |
Non-Review Responsibilities of Chairs |
O-04-99, M-1-02, M-2-03 |
Accreditation Advisory Committee |
O-05-99 |
Inspector Training Requirements |
O-06-99, M-1-99, M-2-02, M-3-02 |
Inspector Training Requirements |
O-07-99 |
Duties and Responsibilities of Ombudspersons |
O-08-99, M-1-00,M-2-00, M-3-03, M-4-04 |
Selection of Inspectors for Labs Outside N. America |
O-09-99, M-1-02 |
Schedule for Inspector Training Workshops |
O-10-99 |
Reports to ASHI Board of Directors |
O-11-99 |
Review of Federal Register |
O-12-00 |
Inspection expenses for Labs Creating Special Circumstances |
O-13-01, M-1-02, M-2-04, M-3-04, M-4-06 |
Enhanced proficiency testing requirements |
O-14-02 |
Adding/Updating Areas of Accreditation Out of Cycle |
O-15-02 |
Re-Issue of Accreditation Certificate After Change of Director |
O-16-02 |
Issuing Previous Deficiencies to Inspectors |
O-17-03, M-1-03 |
Laboratory Review of Contingency List |
O-18-05, M-1-06 |
Criteria for Waiving Change of Director Inspections |
O-19-05 |
Criteria for Waiving Relocation Inspections |
O-20-06 |
ARB Responsibilities in Approval of New Directors |
O-21-06 |
Approval of Directors for New Technologies |
O-22-06 |
Announced Inspections with only Two Weeks Notice |
O-23-07 |
Co-chair and Commissioner Approval of pass-through laboratories |
O-XX- |
|
| |
| Administrative Policies |
A-01-99 |
Notification of Possible Insurance Claim |
A-02-99 |
Administrative Fee for Appeal |
A-03-99 |
Annual Business Meeting of ARB |
A-04-99 |
Maintenance of Manuals and Forms |
A-05-99 |
Inspector Reimbursement Guidelines |
A-06-99, M-1-07 |
Expenses for International Inspections |
A-07-99 |
Expenses for Ad Hoc Inspections |
A-08-99, M-1-02 |
Gifts for Exemplary Inspectors |
A-09-99, M-1-02 |
Fee for Review of Director Portfolio |
A-10-99, M-1-02, M-2-04, M-3-07 |
Record Retention |
A-11-99, M-1-02 |
Inspector’s Copy of Lab’s Documentation |
A-12-00 |
Issuing an Updated ASHI Certificate |
A-13-00, M-1-04 |
Accreditation Application Due Date |
A-14-00-retired |
|
A-15-00, M-1-03 |
Penalty fee for late applications |
A-16-02 |
Director Training Review Committee Reports |
A-17-02, M-1-03 |
Laboratory Review Contingency Lists |
A-18-02 |
Director Training Portfolio Reviews by Commissioners |
A-19-04 |
ARB Handling of Reported Sentinel Events – TABLED 3/30/07 |
A-20-07 |
Expenses for Inspections of Laboratories in North America |
A-xx- |
|
